Fresenius Kabi Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL recall: Due to a label mix-up

What the company announced

FOR IMMEDIATE RELEASE – 8/4/2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL due to a label mix-up. The MicroVault labeled as Morphine 2 mg/1 mL, may contain a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. This recall is being conducted to the user level.

Use of a MicroVault labeled as Morphine Sulfate Injection 2 mg/mL containing a prefilled syringe of Dilaudid (hydromorphone HCl) 0.5 mg/0.5 mL has a reasonable probability of causing serious adverse health consequences, including life-threatening respiratory depression and death. Patients at greatest risk include individuals who do not use opioids on a regular basis, those with underlying respiratory disease, pediatric patients, and those who are also taking central nervous system (CNS) depressants. To date, no adverse event reports have been received for this lot number.

Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

• Product Name/Product Size: Morphine Sulfate Injection USP, Simplist® 2 mg / 1 mL, 1 mL fill in a single dose 1 mL Simplist® prefilled syringe · Unit of Use NDC Number: 76045- 004-01 · Unit of Sale NDC Number: 76045- 004-11 · Product Code: 764411 · Lot Number: 6402820 · Expiration Date: 12/2028 · First Ship Date: 01/29/2026 · Last Ship Date: 06/09/2026

Product was distributed nationwide to distributors and wholesalers.

Fresenius Kabi is notifying its distributors and customers and is arranging for return of the recalled product.

If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing, or using the lots and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.

Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time, or send an e-mail to either [email protected] or [email protected] .

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm

Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

For return kits and 222 forms please contact Inmar Rx Solutions at 1-855-860-7311, from 9 a.m. to 5 p.m. Eastern Standard Time.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Fresenius Kabi

Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company’s broad portfolio enables access to high-quality care across emergency medicine, surgery, oncology, intensive care, and at home – reaching 450 million patients each year.

Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology including infusion pumps, cell and gene therapy devices, disposables, and world-leading blood collection systems; and intravenous generic drugs and fluids that advance essential patient care worldwide. For more information, please visit www.fresenius-kabi.com.

As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.